FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73729–73752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2002
ADHESIVE 14
K022973 · KLE
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
MICROHYBRID 12
K022974 · EBF
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
ETCHING 15
K022975 · EBF
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS
Digirad Corp.
Radiology · 64d
Cleared Nov 22, 2002
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
K023252 · DJR
Icn Biomedicals, Inc.
Toxicology · 53d
Cleared Nov 22, 2002
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
K023352 · JJY
Maine Standards Co.
Chemistry · 46d
Cleared Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 22, 2002
BLOCKING TRAY
K023636 · IYE
Southeastern Radiation Products, Inc.
Radiology · 23d
Cleared Nov 22, 2002
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL...
K023665 · JEY
Bioplate, Inc.
Dental · 22d
Cleared Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · JAK
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · MQB
Canon USA, Inc.
Radiology · 14d
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 22, 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · LLZ
Acuson Corp.
Radiology · 10d
Cleared Nov 21, 2002
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151
K014269 · MYE
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 329d
Cleared Nov 21, 2002
EQUILASE SYSTEM
K022464 · GEX
Equilasers, Inc.
General & Plastic Surgery · 118d
Cleared Nov 21, 2002
ALPHATRAC, MODEL A 205
K022652 · ITI
Teftec Corp.
Physical Medicine · 104d
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · JDI
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 21, 2002
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K022916 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 79d
Cleared Nov 21, 2002
TRX VERTICAL POSITIONER
K023426 · ITI
Motion Concepts
Physical Medicine · 41d
Cleared Nov 21, 2002
WIZAIR COMPRESSION SYSTEM
K023573 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 28d
Cleared Nov 21, 2002
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
K023585 · FPA
Intravascular Incorporated
General Hospital · 27d
Cleared Nov 21, 2002
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
K023622 · DWF
Stockert Instrumente GmbH
Cardiovascular · 23d
Cleared Nov 21, 2002
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
K023711 · FLL
Acute Ideas Co. , Ltd.
General Hospital · 17d